MedTrace Logo

A Bioequivalence Study of Two Different Dosage Form of Genakumab

NCT06451848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-02-11

No results posted yet for this study

Summary

The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.

Conditions

  • Gouty Arthritis (GA)

Interventions

DRUG

Genakumab Injection (T, Solution for injection)

A single dose of subcutaneous injection of Genakumab（Solution for injection, liquid formulation）200 mg on Day 1

DRUG

Genakumab for Injection (R, Powder for solution for injection)

A single dose of subcutaneous injection of Genakumab（Powder for solution for injection, lyophilized formulation) 200 mg on Day 1

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2024-11-29
Completion
2025-01-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451848 on ClinicalTrials.gov